[Combination therapy of azintamid and domperidone in functional dyspepsia: a randomised, double-blind, placebo-controlled trial].

OBJECTIVE: To study the efficacy and safety of combined therapy of compound azintamid and domperidone in functional dyspepsia. METHODS: A randomised, double-blind, placebo-controlled trial. Two hundred and eight patients with functional dyspepsia were randomly grouped into group A (experimental group, 102 cases) and group B (control group, 106 cases). The patients in the group A were given 2 tablets of compound azintamid 3 times a day in addition to domperidone 10 mg 3 times per day for four weeks. The patients in the group B were only given domperidone 10 mg 3 times per day for 4 weeks. The therapeutic efficacy was evaluated by modified Severity of Dyspepsia Assessment (mSODA) and Global Patient Assessment (GPA). RESULTS: Subscore in mSODA: the change of bloating/pain intensity score in group A is -12.35 ± 5.48 while group B is -10.52 ± 4.65 (P = 0.009), the change of non-bloating/pain symptoms score in group A is -5.75 ± 3.31 while group B is -4.86 ± 2.65 (P = 0.033), and the change of satisfaction score in group A is 7.09 ± 3.78 while group B is 5.62 ± 3.54 (P = 0.004). The response rate in group A is 89.2% which is significantly higher than 76.4% in group B (P = 0.015). Other symptoms for response assessment included loss of appetite, early satiety, fullness after meal, diarrhea. No severe side-effect was found in both groups. CONCLUSIONS: Combined therapy of compound azintamid and domperidone may lead to bigger improvement in overall efficacy and health related quality of life in patients with functional dyspepsia than use of motility medicine alone. Potential mechanisms that may account for the efficacy of compound azintamide in functional dyspepsia include modulation of visceral sensitivity and/or gastrointestinal motility.